Ocular Therapeutix’s (NASDAQ:OCUL) results from its second Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA, a bioresorbable intracanalicular depot, for the treatment of ocular itching associated with chronic allergic conjunctivitis failed to achieve statistical significance.
The single primary endpoint of the trial was the difference in the mean scores in ocular itching between the treatment group and the placebo comparator group at three time points seven days following insertion of the depots and was not achieved.
In addition, the trial did not achieve the requirement of at least a 0.5 unit difference at all three time points seven days following insertion of the depots and at least a 1.0 unit difference at the majority of the three time points between the treatment group and the placebo group seven days following insertion of the depots.
“We are disappointed that the primary endpoint of ocular itching associated with allergic conjunctivitis was not achieved in our second Phase 3 trial in these patients, and this result is inconsistent with what we saw in our first Phase 3 trial,” Amar Sawhney, president, CEO and chairman, said in a statement.
The company is currently in the process of conducting an analysis of the data from the second Phase 3 trial to fully understand the difference in efficacy between the two Phase 3 trials. It also plans to meet with the FDA to discuss the results and chart an appropriate path forward for the development of DEXTENZA for the treatment of allergic conjunctivitis.
“We remain confident in the potential of our innovative sustained release platform to address diverse applications in ophthalmology,” Dr. Sawhney added. “We look forward to the July 2016 PDUFA date for DEXTENZA for the treatment of post-surgical ocular pain.”